A San Francisco, California-based food company, Fong Kee Tofu Co., Inc., and its owners, Jen Ying Fong, Suny Fong and Yan Hui Fan, have agreed not to process or distribute food until it has been demonstrated to the U.S. Food and Drug Administration that its facility and practices comply with federal food safety requirements.

On Feb. 9, 2015, a federal judge of the Northern District of California approved a consent decree of permanent injunction against Fong Kee Tofu Co., Inc. for unsanitary conditions at the company’s food processing facility, among other violations. Fong Kee Tofu Co., Inc. processes, manufactures, prepares, packs, labels, holds and distributes soy products, such as tofu and soybean drink.

During previous FDA inspections, investigators found and documented numerous unsanitary conditions at the company that may have resulted in the contamination of their products. Further, there were violations related to controlling pests, protecting against the contamination of food with filth, and misbranding their products.

The FDA issued a Warning Letter to the company and its owners in March 2012. The owners promised to make corrections in their production operations, but the FDA has continued to find and document unsanitary conditions.

“Our goal is to protect the public’s health from potentially harmful food contamination and when a company refuses to comply with the Current Good Manufacturing Practices FDA will take action,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “If and when Fong Kee Tofu Co., Inc. is permitted to resume operations, FDA plans to continue monitoring its compliance with FDA food safety rules.”

Under the consent decree, Fong Kee Tofu Co., Inc. and its officers cannot process or distribute food until they demonstrate that their sanitary practices, facility and processing equipment are suitable to prevent contamination in the food that they process, prepare, store and handle. Fong Kee Tofu Co., Inc. must, among other things, retain an independent sanitation expert and develop a program to eliminate unsanitary conditions at its facility.

To date, the FDA has received no reports of illnesses associated with Fong Kee Tofu Co., Inc.’s products. However, individuals who experience symptoms of foodborne illness after consuming food should contact their healthcare professional. Consumers are also encouraged to report problems with FDA-regulated products to their local consumer complaint coordinator.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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